Irrigation devices, methods, and systems

ABSTRACT

Irrigation devices, methods, and systems are disclosed. The system comprises a catheter with one or more lumens and an expandable portion. One or more pumps are used to supply a mixture of contrasting and dilating agents in an interior kidney volume and flush a portion of the mixture out of the interior kidney volume. The method comprises placing a catheter into the interior kidney volume through a ureter, occluding a portion of the ureter with a distal end of the catheter, forming an exit port through an exterior kidney surface, flowing the contrasting and dilating agents through the one or more lumens to supply the mixture in the interior kidney volume, and flushing a portion of the mixture out of the exit port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of U.S. application Ser. No.15/402,946, filed Jan. 10, 2017, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Patent Application No.62/277,373, filed Jan. 11, 2016, all of which are incorporated byreference in their entireties.

TECHNICAL FIELD

Aspects of the present disclosure generally relate to medical devicesand procedures. In particular, some aspects relate to irrigationdevices, methods, and systems used in percutaneous nephrolithotomy(“PCNL”) procedures.

BACKGROUND

PCNL procedures are used to remove kidney stones from a calyx of akidney. The prerequisite for most PCNL procedures is the establishmentof a satisfactory nephrostomy tract, which can be achieved by aurologist using an antegrade approach (from outside a body into thecalyx) or a retrograde approach (from the ureter into the calyx). Theantegrade approach is most commonly used; however, the retrogradeapproach can provide numerous benefits to many patients, such aspositional advantages that prevent injury, decreased radiation exposure,optimal calyceal selection, and potentially decrease operative time.

Limited visualization discourages the retrograde approach. Fluoroscopymay overcome this limitation, but it only provides a two dimension viewof the kidney, making it difficult for the surgeon to determine exactlywhich calyx has been accessed by the nephrostomy tract. Irrigationtechniques are often used in PCNL procedures to flush each calyx. Someof these techniques utilize fluids that can enhance the images byprovided by fluoroscopy. Yet, because the kidney naturally drains outinto the ureter, these techniques have heretofore proven incompatiblewith the retrograde approach.

Further improvements are required to make the benefits of the retrogradeapproach more accessible.

SUMMARY

Aspects of the present disclosure relate to irrigation devices, methods,and systems. Numerous aspects of the present disclosure are nowdescribed.

One aspect is an irrigation system. The system may comprise a catheterincluding a first lumen, a second lumen, and an expandable portion. Afirst pump may flow a dilating agent from a first reservoir and throughthe first lumen, whereas a second pump may flow a contrasting agent froma second reservoir and through the second lumen. The first and secondpumps may be operable to supply a mixture of the contrasting anddilating agents in an interior kidney volume, and flush a portion of themixture out of an exit port formed in the interior kidney volume.

Aspects of this system may additionally and/or alternatively include oneor more of the features set forth below. The catheter may have an innerdiameter, and the first and second lumens may be defined by an interiorsidewall that spans the inner diameter. The catheter may have an outerdiameter, and the expandable portion may have an outer diameter coaxialtherewith. The catheter may have a longitudinal axis, and the expandableportion may be a surface of revolution about the longitudinal axis. Theexpandable portion may be a balloon, which may be located at a distalend of the catheter. The first and second pumps may be located at aproximal end of the catheter. The proximal end of the catheter may belocated in a sterile field.

The system may further comprise at least one switch for operating thefirst and second pumps. The first and second reservoirs may be removablyattached to the first and second pumps. The at least one switch mayoperate the first pump at a steady flow rate, and the second pump at avariable flow rate. The system may further comprise at least one sensorconfigured to detect an actual measure in the interior kidney volume.The actual measure may include a pressure measure, and the at least onesensor may comprise a pressure sensor configured to detect the pressuremeasure. Either or both of the first and second pumps may be operable inresponse to the pressure measure. The pressure sensor may be attached tothe distal end of the catheter. The actual measure may include aradiopacity measure, and the at least one sensor may comprise an imagingsensor configured to detect the radiopacity measure. Either or both ofthe first and second pumps may be operable in response to theradiopacity measure.

Another aspect is a method for irrigating an interior kidney volume incommunication with a ureter. The method may comprise placing a distalend of a catheter into the interior kidney volume through a ureter, andoccluding a portion of the ureter with an expandable portion of thecatheter. An exit port may be formed in an exterior kidney surface. Themethod may comprise flowing a different fluid through either or both ofat least two lumens in the catheter to supply a mixture in the interiorkidney volume, and flushing a portion of the mixture out of the interiorkidney volume through the exit port.

Aspects of this method may additionally and/or alternatively include oneor more of the features set forth below. The expandable portion of thecatheter may comprise a balloon, and the occluding step may furthercomprise expanding the balloon. Some aspects may further comprise asecond catheter including a distal tip and at least one lumen, whereinthe exit port may be located on the distal tip and in communication withthe at least one lumen; in which case, the forming step may compriseinserting the distal tip into the interior kidney volume through anexterior kidney surface. At least one pump may be configured to flow thedifferent fluids through either or both of the at least two lumens, andthe flowing steps may comprise operating the at least one pump. Themethod may further comprise operating the at least one pump to maintaina constant volume of the mixture inside of the interior kidney volume.

Still another aspect is a method for irrigating a kidney. The method maycomprise placing a distal end of a catheter into an interior kidneyvolume through a ureter, the catheter having a first lumen and a secondlumen. A portion of the ureter may be occluded with an expandableportion of the catheter. A nephroscope may be inserted into the interiorkidney volume to form an exit port. The method may further compriseflowing a contrasting agent through the first lumen and a dilating agentthrough the second lumen to supply a mixture of the contrasting anddilating agents in the interior kidney volume, and flushing a portion ofthe mixture out of the interior kidney volume through the exit port.

Aspects of this method may additionally and/or alternatively include oneor more of the features set forth below. The placing step may furthercomprise inserting the distal end of the catheter into a urethra, andguiding the distal end into a urethra, through a bladder, through theureter, and into the interior kidney volume. The nephroscope may have arigid body with a distal tip. The exit port may be located on the distaltip, such that the inserting step comprises inserting the distal tipinto the interior kidney volume through an exterior kidney surface. Theexpandable portion of the catheter may comprise a balloon, and theoccluding step may further comprise expanding the balloon. This methodmay further comprise, prior to the occluding step, seating theexpandable portion of the catheter at a ureteropelvic junction. Prior tothe placing step, this method may comprise fragmenting a kidney stone inthe interior kidney volume to form a plurality of stone fragments. Afirst pump may be operable to flow the dilating agent, and a second pumpmay be operable to flow the contrasting agent, such that the methodcomprises operating the first and second pumps to maintain a ratio ofthe dilating and contrasting agents in the interior kidney volume. Thismethod may further comprise detecting, with at least one sensor, anactual measure in the interior kidney volume, establishing a targetmeasure in the interior kidney volume, and operating the first andsecond pumps to obtain the target measure. The actual and targetmeasures may be relative to the pressure in the interior kidney volume,or opacity of the mixture in the interior kidney volume.

It may be understood that both the foregoing summary and the followingdetailed descriptions are exemplary and explanatory only, neither beingrestrictive of the inventions claimed below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate exemplary aspects that, togetherwith the written descriptions, serve to explain the principles of thisdisclosure.

FIG. 1 depicts an exemplary irrigation system accordance with thepresent disclosure, wherein the system comprises a device and a fluidsource.

FIG. 2 is a view of an exemplary distal end of the device of FIG. 1.

FIG. 3 is a view of an exemplary fluid source.

FIG. 4A depicts an exemplary method in accordance with the presentdisclosure.

FIG. 4B depicts another exemplary method.

FIG. 5 depicts another exemplary fluid source.

FIG. 6 depicts yet another exemplary fluid source

FIG. 7 is a section view of the fluid source of FIG. 6.

DETAILED DESCRIPTION

The present disclosure is now described with reference to exemplaryaspects of irrigation devices, methods, and systems. Some aspects aredepicted and/or described with reference to a PCNL procedure, whereinirrigation techniques are used to flush a kidney with a mixture ofdifferent fluids. A plurality of kidney stone fragments may be flushedout of the kidney with the mixture. The plurality of stone fragments maybe formed by fragmenting a kidney stone in advance. Any reference to aparticular procedure (such as PCNL), targeted area of treatment (such asa kidney), technique (such as irrigation), or different fluids (such asdilating and contrasting agents) is provided for convenience and notintended to limit the present disclosure unless claimed. Accordingly,the concepts and novelty underlying each aspect may be utilized for anyanalogous device or method, medical or otherwise.

The directional terms “proximal” and “distal” are used to describerelative components and features of the present disclosure. Proximalrefers to a position closer to the exterior of the body or a user,whereas distal refers to a position closer to the interior of the bodyor further away from the user. The term “elongated” as used hereinrefers to any object that is substantially longer in relation to itswidth, such as an object having a length that is at least two timeslonger than its width. Some elongated objects, for example, are axiallyextending in a proximal or distal direction along an axis. Unlessclaimed, these directional terms are provided for convenience and notintended to limit the present disclosure to a particular direction ororientation.

As used herein, the terms “comprises,” “comprising,” or like variation,are intended to cover a non-exclusive inclusion, such that a device ormethod that comprises a list of elements does not include only thoseelements, but may include other elements not expressly listed orinherent thereto. Unless stated otherwise, the term “exemplary” is usedin the sense of “example,” rather than “ideal.”

One aspect of the present disclosure is depicted in FIGS. 1-3 as acatheter 10 with a distal end 11, a proximal end 15, and an elongatedcatheter body 14 extending therebetween. As shown in FIG. 1, the distalend 11 of catheter 10 may be placed into an interior volume 2 of akidney 1 using a retrograde approach, wherein distal end 11 is insertedinto a urethra 6, advanced through a bladder 5, and then advancedthrough a ureter 4 for placement adjacent interior kidney volume 2. All,or at least an implanted portion, of catheter 10 may be made of aflexible biocompatible material, like silicone.

Distal end 11 of catheter 10 is configured to occlude a portion ofureter 4. In the aspect of FIGS. 1-2, an expandable portion 12 ofelongated catheter body 14 is expanded to occlude ureter 4 by forming apressure seal with the interior surfaces of ureter 4, thereby preventingany fluids from draining out of interior kidney volume 2 through ureter4. Expandable portion 12 is illustrated in FIG. 2 as an occlusionballoon located adjacent distal end 11. An air supply line may beprovided to inflate the balloon. This aspect of expandable portion 12has an outer diameter coaxial with the outer diameter of catheter, andan outer surface formed as a surface of revolution about a longitudinalaxis of distal end 11. Expandable portion 12 may either form a seal withureter 4 or be seated in a utereopelvic junction 3.

Catheter 10 may have at least two lumens extending therethrough. Theaspect of catheter 10 depicted in FIG. 2, for example, has a first lumen16A and a second lumen 16B extending along the length of catheter 10between distal end 11 and proximal end 15. Each lumen 16A, 16B is opento distal end 11 and proximal end 15. As illustrated, catheter 10 has aninner diameter that is divided by a sidewall 11C to define a firstdistal end opening 11A and a second distal end opening 11B. Although notrequired, openings 11A and 11B may have a semi-circular shape at distalend 11.

Proximal end 15 of catheter 10 is attached to a fluid source 30. Asshown in FIG. 1, fluid source 30 includes a first reservoir 30A attachedto a first supply line 32A and a second reservoir 30B attached to asecond supply line 32B. Each of supply lines 32A and 32B are attachedto, respectively, one of first and second lumens 16A and 16B by amanifold 33. One aspect of fluid source 30 is depicted in FIG. 3 as apair of syringes 31A and 31B, each housing one of the reservoirs 30A or30B. Each syringe 31A and 31B has a plunger 36A or 36B configured toflow a fluid from reservoirs 30A, 30B, through supply lines 32A, 32B,and into lumens 16A, 16B, for distribution in interior kidney volume 2.Each plunger 36A and 36B serves as a manually operated pump in thisaspect. A surgical drape 8 is depicted in FIG. 3. Proximal end 15 ofcatheter 10 and fluid source 30 are located outside a sterile fielddefined by drape 8.

Each reservoir 30A and 30B is configured to hold a fluid. In FIG. 3, forexample, first reservoir 30A holds a first fluid, such as a dilatingagent like saline, while second reservoir 30B holds a second fluid, suchas a contrasting agent like iodine or barium. The exterior surface ofkidney 1 (FIG. 1) is a tough, multi-layered tissue impermeable to thefirst and second fluids. Plungers 36A and 36B are operable to supply amixture of the first and second fluids in interior kidney volume 2,which acts like a pressure vessel to contain the mixture. The mixturemay be supplied to achieve certain benefits. In some aspects, themixture is supplied to flush contaminants out of interior kidney volume2 through an exit port 22 formed in kidney 1 (FIG. 1). In other aspects,the mixture is supplied to enhance the visibility of interior kidneyvolume 2 when viewed through a medical imaging device 9 (FIG. 6). Forexample, the ratio of contrasting and dilating agents in the mixture maybe optimized by operating plungers 36A and 36B to achieve a targetedradiopacity measure in interior kidney volume 2, thereby enhancing thevisibility of each calyx in kidney 1 when viewed with imaging device 9(FIG. 6).

Plungers 36A and 36B are operable to flush at least portion of themixture out of exit port 22. As shown in FIG. 1, exit port 22 is formedin interior kidney volume 2 by placing a distal tip 21 of a secondcatheter 20 through the exterior kidney surface. Distal tip 21 may beplaced in interior kidney volume 2 using an antegrade approach, whereindistal tip 21 is inserted through an exterior skin 7 of a body and thenpassed through various bodily tissues, including the exterior kidneyssurface, for placement in interior kidney volume 2.

Numerous methods for using catheter 10 and fluid source 30 are nowdescribed with reference to FIGS. 1-4. One example is a method 50 (FIG.4A) for irrigating interior kidney volume 2. Method 50 may be performedafter an initial step of fragmenting a kidney stone in the interiorkidney volume to form a plurality of stone fragments. Any fragmentationtechnique may be used, including those based on a disruptive energy suchas that applied by sound waves, lasers, etc.

An exemplary method 50 comprises a step 51 of placing the distal end 11of catheter 10 adjacent interior kidney volume 2 through ureter 4. Step51 may be performed using a retrograde approach, wherein step 51 furthercomprises a step for inserting distal end 11 into urethra 6; and a stepfor guiding distal end 11 through bladder 5 and ureter 4 for placementadjacent interior volume 2. Another step 52 comprises occluding aportion of ureter 4 with distal end 11. As described above, catheter 10may have an expandable portion 12, such that step 52 further comprisesexpanding portion 12. If portion 12 is a balloon, then step 52 mayfurther comprise inflating the balloon. In some aspects, step 52 mayfurther comprise seating expandable portion 12 at ureterojunction 3 by,for example, applying a proximally-directed force to elongated catheterbody 14.

In this method 50, another step 53 comprises forming exit port 22 byinserting the distal tip 21 of second catheter 20 through the exteriorsurface of kidney 1 (FIG. 1). Second catheter 20 may be a nephroscopewith a distal tip, wherein step 53 comprises inserting the tip of thenephroscope into interior kidney volume 2 through exterior skin 7 andthe exterior kidney surface using an antegrade approach. In someaspects, step 53 may be preceded by a step of inserting a distal end ofa sheath through an opening in the exterior surface of kidney 1, anddilating the sheath to seal the exterior surfaces of the tract againstthe interior surface of the opening. Accordingly, step 53 may furthercomprise inserting the nephroscope into kidney 1 through a lumen of thetract. A grommet, o-ring, or like sealing element may be placed aroundthe exterior surfaces of the nephroscope to prevent unwanted fluid flow.

Method 50 further comprises a step 54 of flowing a different fluidthrough either or both of at least two lumens 16A, 16B of catheter 10 tosupply a mixture in interior kidney volume 2; and a step 55 of flushingat least a portion of the mixture out of exit port 22. Each of steps 54and 55 may be performed by operating plungers 36A and 36B. For example,each step 54, 55 may further comprise a step for depressing either orboth of plungers 36A or 36B by a first amount to flow either or both ofthe different fluids from reservoirs 30A, 30B, through supply lines 32A,32B, and into lumens 16A, 16B, to supply the mixture in interior kidneyvolume 2. Method 50 may comprise another step for depressing plungers36A, 36B by a second amount to flush a portion of the mixture out ofexit port 22. For example, plungers 36A and 36B may be depressed topressurize the mixture in interior kidney volume 2 until a portion ofthe mixture flows out of exit port 22.

Another aspect of the present disclosure is shown in FIG. 5 and nowdescribed with reference to catheter 10, exit port 20, and a fluidsource 130, which is an alternate aspect of fluid source 30. Catheter 10is described above. Source 130 has a first reservoir 130A and secondreservoir 130B, each being configured to hold a fluid. Reservoir 130Amay hold a first fluid, such as the dilating agent, while secondreservoir 130B holds a second fluid, such as the contrasting agent.

In contrast to above, fluid source 130 has a first pump 136A and asecond pump 136B. Pumps 136A, 136B may comprise any known pumpingtechnology. As shown in FIG. 5, for example, each pump 136A and 136B isan electric pump configured to pull the first and second fluids fromreservoirs 130A and 130B and into interior kidney volume 2 through oneof a first supply line 132A and a second supply line 132B. A power cable134A or 134B provides electricity to each pump. First and second pumps136A and 136B may be operated by one or more control switches. Forexample, first pump 136A of FIG. 5 is operated by moving a toggle switch137A into an “on” position to flow the first fluid at a constant flow,thereby ensuring that kidney 1 will remain dilated until toggle switch137A is moved into an “off” position. Second pump 136B of FIG. 5 isoperated by moving a biased switch 137B into an “on” position to flowthe second fluid, thereby ensuring that the mixture will be increasinglyradiopaque until biased switch 137B is released. Accordingly, pumps 136Aand 136B, like plungers 36A and 36B, are operable to supply a mixture ofthe contrasting and dilating agents in interior kidney volume 2, andflush one or more contaminants out of exit port 22 (FIG. 1) with aportion of the mixture.

Aspects of method 50 may be used with fluid source 130. For example,because pumps 136A and 136B perform the function of plungers 36A and36B, steps 54 and 55 may further comprise activating either or both ofswitches 137A and 137B to flow either or both of the first and secondfluids to supply a mixture to interior kidney volume 3 and flush aportion of the mixture out of exit port 22. A further step may compriseactivating switch 137B, for example, to adjust the radiopacity of themixture. Another step may comprise activating either or both of switches137A, 137B to maintain a targeted ratio or amount of the dilating andcontrasting agents in interior kidney volume 2. In some aspects, thetargeted ratio of dilating to contrasting agents may be maintained at aratio of approximately 1:1 to facilitate placement of first and/orsecond catheter 10, 20, as described above, and then gradually changedto a ratio of approximately 1:0 for another step of the procedure. Anyrelative values may be used, and any such values may be varied, asneeded, by activating either or both of switches 137A and 137B.

Another aspect of the present disclosure is now described with referenceto catheter 10 and a fluid source 230, which is another alternate fluidsource 30. Catheter 10 is described above. An exemplary aspect of fluidsource 230 is depicted in FIGS. 6 and 7 as including a first reservoir230A, a second reservoir 230B, and a pump manifold 233. Source 230 has afirst pump 236A and a second pump 236B, either of which may comprise anyknown pumping technology. As shown in FIG. 7, reservoir 230A, forexample, is removably attached to an engagement portion 238A of manifold233. Reservoir 230B may be identically structured. A set of ports 239Aand 239B are illustrated in FIGS. 6 and 7 as extending through manifold233 to allow another fluid to be introduced into the mixture. Therespective first and second fluids flow from pumps 236A and 236B andinto interior kidney volume 2 through a first supply line 232A and asecond supply line 232B. Accordingly, first and second reservoirs 230Aand 230B are removably attached to first and second pumps 236A and 236B.

Fluid source 230 comprises at least one sensor configured to detect ameasure in interior kidney volume 2. A first sensor 240 and a secondsensor 242 are depicted in FIG. 6. Any sensing technology, orcombination of such technologies, may be used. As shown, first sensor240 detects a pressure measure in interior kidney volume 2. Sensor 240may, for example, be a strain gauge attached to distal end 11 ofcatheter 10. Second sensor 242 of FIG. 6 detects a radiopacity measurein volume 2. Sensor 242 may, for example, be an active-pixel sensorlocated outside of the sterile field and configured detect the measureby sampling pixel color and contrast in an image 90 taken by an imagingmachine 9 (FIG. 6).

First and second pumps 236A and 236B of FIG. 6 are electronic pumpsoperated by a processor 237, which may be any known processing device,such as a computer. First and second sensors 240 and 242 communicatewith processor 237 using a wired or wireless connection to provide forautomated control of first and second pumps 236A and 238B. For example,either or both of first and second pumps 236A and 236B may be operatedby processor 237 in response to first and/or second sensors 240 and 242.To avoid unwanted backflow or over-dilating kidney 1, a pressuresafeguard may be realized by operating either or both of first andsecond pumps 236A and 236B in response to the pressure measure detectedby sensor 240. For example, an upper limit to fluid pressure in interiorkidney volume 2 may be relative to pyelovenous backflow, which occurs atapproximately 30 mm Hg (or 0.58 psi) or greater; pyelotubular backflow,which occurs at approximately 40 mm Hg (or 0.77 psi) or greater;pyelolymphatic backflow, which occurs at approximately 60 mm Hg (or 1.16psi) or greater; or forniceal rupture, which occurs at approximately 100mm Hg (or 1.93 psi) or greater. Either or both of pumps 236A and 236Bmay be operated in response to the pressure measure obtained by firstsensor 240 to ensure that any one or more of these upper limits are notexceeded. In some aspects, either or both of pumps 236A and 236B may beoperated to maintain an operating pressure of approximately 0 mmHg toapproximately 60 mmHg (or approximately 0 psi to approximately 1.16 psi)in interior kidney volume 2.

Either or both of first and second pumps 236A and 236B may also beoperated to flush kidney 1 with the mixture. Thus, to continue thisexample, a targeted ratio or amount of fluids in volume 2 may bemaintained, even if kidney 1 is continually flushed, by operating eitheror both of the first and second pumps 236A and 236B in response to theradiopacity measure detected by second sensor 242. For example, at leastsecond pump 236B may be operated in response to sensor 242 to maintainthe targeted ratio or amount of contrasting and dilating agents in themixture, even as a portion of the mixture is continuously flushed out ofexit port 22. The targeted ratio may also be varied, such that either orboth of pumps 236A and 236B may be operated in response to sensor 242 soas to maintain a first targeted ratio during an initial part of aprocedure and a second targeted ratio during a subsequent part of aprocedure. For example, a first ratio of approximately 1:1 for thedilating and contrasting agents may be maintained to facilitateplacement of first or second catheters 10, 20, whilst a second ratio of1:0, dilating to contrasting agent, may be maintained thereafter. Anyrelative values may be used. This transition may be rendered in agradual or abrupt manner by operation of either or both of pumps 236Aand 236B.

Similar to above, aspects of method 50 may be used with fluid source230. For example, pumps 236A and 236B may be operated in accordance withsteps 54 and 55 by using processor 237 to supply the mixture and flush aportion of the mixture out of an exit port 22 formed in interior kidneyvolume 2. Step 54 may be implemented with method 60 as provided in FIG.4B. The placing, occluding, and forming steps of method 60 may beperformed as discussed above in method 50. Method 60 comprises a step 61for detecting, with at least one sensor, a measure in interior kidneyvolume 2, such as the pressure or radiopacity measures described abovewith reference to first and second sensors 240 and/or 242. Anothermethod step 62 comprises establishing, with processor 237, a targetmeasure in interior kidney volume 2. For example, a target flow rate ofthe dilating fluid may be established to regulate a pressure measure involume 2. Alternatively, a target ratio or amount of dilating andcontrasting agents may be established to maintain a radiopacity measure.Another method step 63 comprises modifying, with processor 237, the flowof either of the dilating or contrasting agent to obtain the targetmeasure, for example, by operating either of the first and second pumps236A and 236B.

Each device, method, and system has been described as operable to supplya mixture of different fluids in interior kidney volume 2, and flush aportion of the mixture out of volume 2. This disclosure allows themixture to be used in an irrigation technique that is both compatiblewith a retrograde approach and provides a means for enhancing thevisibility of interior kidney volume 2. Moreover, by flowing the fluidsas described, the contrast of the mixture may be modified to anyparticular level, and maintained indefinitely at that level, even ifkidney 1 is flushed continually. Numerous alternative aspects are nowdescribed. Each of these alternative aspects may enhance the performanceof the any device, method, or system described herein. Any feature ofany alternative aspect described herein may be combined with any otherfeature described herein, each possible variant being part of thepresent disclosure.

Distal end 11 is described as having an expandable portion 12 configuredto occlude ureter 4. In some aspects, portion 12 is a balloon.Expandable portion 12 may assume any shape, regular or irregular,symmetrical or asymmetrical. For example, portion 12 may be irregularlyshaped to seal a particular ureteropelvic junction 3, or formed of aflexible material that naturally form fits to the contours of ureter 4or junction 3 when expanded. Catheter 10 may have a plurality ofexpandable portions 12, each portion being spaced apart on elongatedcatheter body 14 to seal ureter 4 at a plurality of locations. Althoughdescribed as being expanded by air, portion 12 may alternatively befilled by a fluid. For example, either of lumens 16A, 16B might have aport that opens into portion 12, allowing it to be expanded by eitherthe first or second fluid.

Catheter 10 of FIGS. 1-3 has two lumens 16A and 16B for delivery of twodifferent fluids, although any number of lumens may be provided. Forexample, if expandable portion 12 of catheter 10 is a balloon, then theaforementioned air supply line may be one or more additional lumens thatopen into expandable portion 12 of catheter 10. An exit lumen may beprovided with a pressure relieve valve, thus providing a furthersafeguard against over-dilation of kidney 1. Lumens 16A and 16B aredepicted in FIG. 2 as being approximately equal in size, but may besized differently. Each lumen has also been described as having anopening 11A or 11B with a semi-circular shape. These openings may assumeany shape. For example, a nozzle may be provided in one or both openings11A, 11B to vary the pressure of any fluid delivered therethrough.

First and second fluids have been described as, respectively, a dilatingagent and a contrasting agent. Any fluid types may be used. For example,one of the fluids may include a medicating agent, such as ananti-inflammatory, that is circulated through kidney 1 during aprocedure. Other fluid types may be circulated to further dissolve theplurality of kidney stone fragments, promote the formation of a sealbetween expandable portion 12 and ureter 4, or provide like benefits.These additional fluids may be introduced through manifold 33, passedthrough second catheter 20 (FIG. 1), injected into ports 239A and 239B(FIG. 7), or otherwise provided. Fluid sources 30, 130, and 230 haveeach been described as having two pumps (36A-B, 136A-B, or 236A-B), andtwo reservoirs (32A-B, 132A-B, or 232A-B) for the purpose of flowing thefirst and second fluids. Any number of pumps or reservoirs may beprovided to realize any of these alternative aspects.

Any type of switching and/or sensing technologies may be incorporatedinto any aspect of fluid sources 30, 130, or 230 to aid in circulatingthe mixture, maintaining a characteristic of the mixture, or flushingkidney 1. Processor 237 may be utilized to automate any of thesefunctions of these fluid sources. For example, pumps 236A and 236B maybe operated, with processor 237, according to automated control sequenceresponsive to a signal generated by either or both of sensors 240 and242. Given the variety of sensing technologies, it should be appreciatedthat pumps 236A and 236B may be operated by any sensing technology todeliver a corresponding variety of benefits. For example, one or moreadditional sensors may be configured to detect a measure of blood in thefluid mixture, such that either or both of pumps 236A or 236B may beoperated in response to the one or more additional sensors toautomatically notify the physician if/when a safeguard is tripped,responsively reduce the pressure or increase the opacity of the mixturein interior kidney volume 2, or introduce a medicating agent into themixture.

Any of the method steps described above with reference to exemplarymethods 50 and 60 may be modified to accommodate the structure of any ofthese alternative aspects. For example, method 50 may be modified foruse with an type of fluids, through any number of lumens, etc.; andmethod 60 may be modified for use with any type of sensor, switch,processor, or the like. In either instance, methods 50 and 60 may befurther modified supply the mixture in interior kidney volume 2 andflush one or more contaminants out of interior volume 2.

While principles of the present disclosure are described herein withreference to illustrative aspects for particular applications, thedisclosure is not limited thereto. Those having ordinary skill in theart and access to the teachings provided herein will recognizeadditional modifications, applications, aspects, and substitution ofequivalents all fall in the scope of the aspects described herein.Accordingly, the present disclosure is not to be considered as limitedby the foregoing description.

The invention claimed is:
 1. An irrigation system, the systemcomprising: a catheter including a first lumen, a second lumen, and anexpandable portion; a first pump for flowing a dilating agent from afirst reservoir, through the first lumen, and into an interior kidneyvolume; a second pump for flowing a contrasting agent from a secondreservoir, through the second lumen, and into the interior kidneyvolume; and at least one image sensor configured to detect a radiopacitymeasure, wherein the second pump is operable in response to theradiopacity measure, wherein the first and second pumps are operable tosupply a mixture of the contrasting and dilating agents in the interiorkidney volume and flush a portion of the mixture out of an exit port. 2.The system of claim 1, wherein the expandable portion of the catheter isa balloon located at a distal end of the catheter.
 3. The system ofclaim 1, further comprising at least one switch for operating the firstand second pumps.
 4. The system of claim 1, wherein the first and secondreservoirs are removably attached to the first and second pumps.
 5. Thesystem of claim 1, wherein the first pump is operable at a steady flowrate, and the second pump is operable at a variable flow rate.
 6. Thesystem of claim 4, further comprising a pressure sensor configured todetect a pressure measure, and wherein the first pump is operable inresponse to the pressure measure.
 7. The system of claim 1, furthercomprising a pressure sensor, wherein the pressure sensor is configuredto detect a pressure measure, and the first pump is operable in responseto the pressure measure.
 8. An irrigation system, the system comprising:a catheter including a first lumen, a second lumen, and an expandableportion, wherein the expandable portion is positioned at a distal end ofthe catheter; a first pump for flowing a dilating agent from a firstreservoir, through the first lumen, and into an interior kidney volume;a second pump for flowing a contrasting agent from a second reservoir,through the second lumen, and into the interior kidney volume; and atleast one image sensor configured to detect a radiopacity measure in theinterior kidney volume, wherein the first and second pumps are operableto supply a mixture of the contrasting and dilating agents in theinterior kidney volume and flush a portion of the mixture out of an exitport, wherein at least one of the first and second pumps are operable todeliver the dilating agent and/or the contrasting agent in order toobtain a target measure in the interior of the kidney volume based onthe measure in the interior of the kidney volume, and wherein the secondpump is operable in response to the radiopacity measure.
 9. The systemof claim 8, wherein the expandable portion of the catheter is a balloonlocated at a distal end of the catheter.
 10. The system of claim 8,further comprising at least one switch for operating the first andsecond pumps, and wherein the first and second reservoirs are removablyattached to the first and second pumps.
 11. The system of claim 8,wherein the first pump is operable at a steady flow rate, and the secondpump is operable at a variable flow rate.
 12. The system of claim 10,further comprising a pressure sensor configured to detect a pressuremeasure, and the first pump is operable in response to the pressuremeasure.
 13. The system of claim 8, further comprising a pressuresensor, wherein the pressure sensor is configured to detect a pressuremeasure, and the first pump is operable in response to the pressuremeasure.
 14. An irrigation system, the system comprising: a catheterincluding a first lumen, a second lumen, and expandable portion; a firstpump for flowing a dilating agent from a first reservoir, through thefirst lumen, and into an interior kidney volume; a second pump forflowing a contrasting agent from a second reservoir, through the secondlumen, and into the interior kidney volume; and at least one imagesensor configured to detect a radiopacity measure in the interior kidneyvolume, wherein the first and second pumps are operable to supply amixture of the contrasting and dilating agents in the interior kidneyvolume and flush a portion of the mixture out of an exit port, andwherein at least one of the first and second pumps are operable todeliver the dilating agent and/or the contrasting agent in order toobtain a target measure in the interior of the kidney volume based onthe measure in the interior of the kidney volume, and wherein at leastone of the first pump and the second pump is operable in response to theradiopacity measure.
 15. The system of claim 14, wherein the expandableportion is a balloon located at a distal end of the catheter.
 16. Thesystem of claim 14, further comprising at least one switch for operatingthe first and second pumps, wherein the first and second reservoirs areremovably attached to the first and second pumps.
 17. The system ofclaim 14, further comprising a pressure sensor, wherein the pressuresensor is configured to detect a pressure measure, and the first pump isoperable in response to the pressure measure, and wherein the secondpump is operable in response to the radiopacity measure.